GI Dynamics has announced that the FDA has placed a hold on enrolment in the company’s ongoing pivotal clinical trial of EndoBarrier Therapy (the ENDO Trial) in the US. Monitoring and data collection involving patients currently enrolled in the ENDO Trial will continue.

The decision to hold further enrolment results from four cases of hepatic abscess, among the 325 subjects currently enrolled in the ENDO Trial. Hepatic abscess is a known event related to the use of EndoBarrier but has recently presented at a higher than anticipated rate in the ENDO Trial. The FDA has therefore requested additional information to further assess the risk:benefit profile of the EndoBarrier in the ENDO Trial.

According to the company, outside of the US the incidence rate of hepatic abscess is approximately 1% based on experience with more than 2,900 units shipped commercially since 2009. GI Dynamics believes that EndoBarrier’s overall risk:benefit profile, as established outside of the US, remains favourable. EndoBarrier therefore continues to be available for use by physicians and patients in the multiple countries where it is approved.

The company has implemented several risk mitigation strategies in the ENDO Trial and is expeditiously working to submit the requested information to the FDA for their review in an effort to resume enrolment.

On a conference call, GI Dynamics' President and CEO Michael Dale said the infections are "likely related to the anchoring system interacting with the duodenum."

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